Aortic Valve Replacement
Conditions
Brief summary
The objective of this observational trial is to determine time to valve failure due to valve deterioration requiring re-intervention and collect/investigate early potential predictors of valve durability (e.g., calcification and hemodynamic deterioration) in RESILIA tissue valves.
Detailed description
Multicenter, prospective, non-randomized, single-arm, observational trial. Subjects will be evaluated at 5, 7, 9, and 11 years post-implant. Up to two hundred fifty (250) total subjects at up to fifteen (15) investigational sites will be enrolled.
Interventions
DIAGNOSTIC_TESTSubjects previously implanted with a RESILIA aortic tissue valve.
Subjects to undergo multi-slice computed tomography and echocardiogram to assess predictors of valve durability in previously implanted Edwards aortic valves with RESILIA tissue.
Sponsors
Edwards Lifesciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. 18 years or older 2. Subject currently has an Edwards pericardial aortic bioprosthesis with RESILIA tissue 3. Provides voluntary written informed consent prior to the first trial related procedure 4. Subject agrees to attend follow-up assessments as specified in the protocol
Exclusion criteria
1. Age 65 years or older at time of aortic valve replacement 2. The Subject is pregnant or planning to become pregnant at the time of screening 3. Re-intervention required on the bioprosthetic aortic valve prior to screening 4. Active endocarditis or history of endocarditis on bioprosthetic aortic valve 5. Estimated life expectancy \<24 months 6. Subjects with history of or current renal failure requiring dialysis 7. Altered mineral metabolism (hyperparathyroidism, parathyroid tumors) 8. Has prior organ transplant or is currently an organ transplant candidate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to bioprosthetic valve failure due to valve deterioration | 11 years post-implant | Time to bioprosthetic valve failure due to valve deterioration is defined as subject requiring valve re-intervention (redo surgery, valve-in-valve) or confirmed study valve-related death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collection of early possible predictors of valve failure including leaflet calcification and morphological/hemodynamic valve deterioration | 5, 7, 9, and 11 years post-implant | 1. Quantification of valve leaflet calcification via core lab evaluated multi-slice computed tomography (MSCT) 2. Hemodynamic performance of the valve and evaluation for possible morphological/hemodynamic valve deterioration confirmed by core lab evaluation of echo-cardiography |
Countries
United States
Outcome results
None listed